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Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects

Phase 1
Completed
Conditions
Diabetes
Healthy
Interventions
Drug: biphasic human insulin 30
Registration Number
NCT01486888
Lead Sponsor
Novo Nordisk A/S
Brief Summary

This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
45
Inclusion Criteria
  • Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
  • Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
  • Non-smoker, defined as no nicotine consumption for at least one year
  • Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L)
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Exclusion Criteria
  • Previous participation in this trial or other clinical trials within the last 3 months
  • Body weight above 87.5 kg
  • Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3
  • History of alcohol or drug abuse
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Formulation Bbiphasic human insulin 30-
Formulation Abiphasic human insulin 30-
Primary Outcome Measures
NameTimeMethod
Maximum serum insulin concentration (Cmax)
Area under the serum insulin concentration-time curve (AUC 0-24 hours)
Secondary Outcome Measures
NameTimeMethod
Area under the serum insulin concentration-time curve (AUC 6-24 hours)
Area under the serum insulin concentration-time curve (AUC 0-6 hours)
Terminal insulin half life (t½)
Area under the serum insulin concentration-time curve (AUC 0-inifinity hours)
Time to maximum serum insulin concentration (tmax)
Adverse events
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